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Comparison of Ba-Duan-Jin and Pregabalin in Patients With Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ba-Duan-Jin
Pregabalin capsule
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Eight Brocades; Ba-Duan-Jin; Baduanjin; Qigong; Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • meet the 1990 American College of Rheumatology (ACR) Research Classification Criteria for fibromyalgia;
  • be between the ages of 18 to 70 years.

Exclusion Criteria:

  • had practiced Ba-Duan-Jin, Tai Chi, yoga or other forms of Qigong exercise within 12 months of their recruitment to the study;
  • be less than 40mm of pain VAS score;
  • had renal failure, and severe depression or anxiety;
  • had any poorly-controlled comorbid medical conditions, such as dementia, cancer, thyroid disease, inflammatory arthritis;
  • pregnancy or planned pregnancy within the study period;
  • patients residing more than 70 miles from the research site.

Sites / Locations

  • Jiao Juan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ba-Duan-Jin group

Pregabalin group

Arm Description

Ba-Duan-Jin therapy: The participants will be guided by a research staff to do the Ba-Duan-Jin therapy for 50 minutes twice weekly for 12 weeks, in the outpatient section of the hospital. Placebo pregabalin capsules: Pregabalin placebo treatment will be administered at bedtime once a day, starting at 150 mg for the first week, and increase to the dose of 300 mg from the second week. After one week, if 300 mg dose is tolerable, then maintain it for 10 additional weeks, if not, then go back to the 150 mg dose for 10 additional weeks.

Wellness education and muscle relaxation exercise program: This program will be held for 50 minutes twice weekly for twelve weeks, containing 10-minute wellness education, 10-minute doctor-patient discussion, and 30-minute guided muscle relaxation exercise. Active pregabalin capsules: As same usage as the placebo pregabalin capsules.

Outcomes

Primary Outcome Measures

The change of the Visual Analogue Scale (VAS) for pain from baseline.
Pain VAS, range, 0 to 100 mm, where higher scores indicated the perceived pain to be more severe.

Secondary Outcome Measures

The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.
A self-administered questionnaire with 10 subscales, measuring fibromyalgia symptoms and function domains. FIQR total score ranges from 0 to 100, with higher scores indicating more severe symptoms.
The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.
The Multidimensional Fatigue Inventory-20 (MFI-20) measures fatigue severity. The MFI-20 total score ranges from 0 to 80, with higher scores indicate more severe fatigue.
The change of the Pittsburgh Sleep Quality Index (PSQI) from baseline.
Scores on the Pittsburgh Sleep Quality Index (PSQI) range from 0 to 21, with higher scores indicating worse sleep quality.
The Beck II Depression Inventory (BDI)
The Beck II Depression Inventory (BDI) assesses the severity of depressive symptoms. Scores range from 0 to 39, with higher scores indicate a greater degree of depression severity.
The change of the Perceived Stress Scale (PSS) from baseline.
The Perceived Stress Scale (PSS) is for measuring the perception of stress and current levels of experienced stress. Scores range from 0 to 56, with higher total score indicating a greater degree of symptom severity.
Global Impression of Change (PGIC) questionnaire evaluated at week 12.
A questionnaire determine any change in overall symptom status from the beginning of the study to its conclusion (score range, 1 [very much improved] to 7 [very much worse).
The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline.
The Short Form-36 Health Status Questionnaire (SF-36), which measured health-related quality of life (range, 0 to 100, with higher scores indicating better perceived health status).

Full Information

First Posted
January 6, 2019
Last Updated
December 3, 2022
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03797560
Brief Title
Comparison of Ba-Duan-Jin and Pregabalin in Patients With Fibromyalgia
Official Title
Comparison the Treatment Effects Between Ba-Duan-Jin and Pregabalin in Patients With Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 22, 2019 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Fibromyalgia is a chronic debilitating musculoskeletal pain syndrome. Pregabalin is the only medication that has been approved to treat fibromyalgia in China. Currently, there has been a growing interest in the development of non-pharmacological therapies. Ba-Duan-Jin is an ancient Chinese exercise for health promotion yet easy to learn. Findings from our previous study showed an effectiveness and good safety of Ba-Duan-Jin in patients with fibromyalgia. This study is to evaluate the effectiveness comparison of Ba-Duan-Jin and pregabalin in managing fibromyalgia symptoms experienced by Chinese patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Eight Brocades; Ba-Duan-Jin; Baduanjin; Qigong; Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ba-Duan-Jin group
Arm Type
Experimental
Arm Description
Ba-Duan-Jin therapy: The participants will be guided by a research staff to do the Ba-Duan-Jin therapy for 50 minutes twice weekly for 12 weeks, in the outpatient section of the hospital. Placebo pregabalin capsules: Pregabalin placebo treatment will be administered at bedtime once a day, starting at 150 mg for the first week, and increase to the dose of 300 mg from the second week. After one week, if 300 mg dose is tolerable, then maintain it for 10 additional weeks, if not, then go back to the 150 mg dose for 10 additional weeks.
Arm Title
Pregabalin group
Arm Type
Active Comparator
Arm Description
Wellness education and muscle relaxation exercise program: This program will be held for 50 minutes twice weekly for twelve weeks, containing 10-minute wellness education, 10-minute doctor-patient discussion, and 30-minute guided muscle relaxation exercise. Active pregabalin capsules: As same usage as the placebo pregabalin capsules.
Intervention Type
Other
Intervention Name(s)
Ba-Duan-Jin
Other Intervention Name(s)
Baduanjin; Eight Brocades; Eight-Section Brocade
Intervention Description
Ba-Duan-Jin is a common form of "self-health-care" Qigong exercise that has been practiced by Chinese people for at least eight hundred years. It consists of eight sets of simple movements. By combining meditation with slow, graceful movements, deep breathing, and relaxation, Ba-Duan-Jin practitioners believe it has the ability to move vital energy (Qi) throughout the body. Ba-Duan-Jin is also considered to be a multicomponent intervention that integrates physical, psychosocial, emotional, spiritual, and behavioral elements. While the biological mechanisms remain unclear, previous clinical trials have demonstrated that Ba-Duan-Jin can improve sleep quality, physical health, and mental health in patients with various chronic diseases
Intervention Type
Drug
Intervention Name(s)
Pregabalin capsule
Intervention Description
Pregabalin is one of the three medications (pregabalin, duloxetine, and milnacipran) that have been approved by the Food and Drug Administration (FDA) to treat fibromyalgia in US, and the only medicine that has been approved in China.
Primary Outcome Measure Information:
Title
The change of the Visual Analogue Scale (VAS) for pain from baseline.
Description
Pain VAS, range, 0 to 100 mm, where higher scores indicated the perceived pain to be more severe.
Time Frame
up to 1 week
Secondary Outcome Measure Information:
Title
The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.
Description
A self-administered questionnaire with 10 subscales, measuring fibromyalgia symptoms and function domains. FIQR total score ranges from 0 to 100, with higher scores indicating more severe symptoms.
Time Frame
Baseline, week 4, week 8, and week 12.
Title
The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.
Description
The Multidimensional Fatigue Inventory-20 (MFI-20) measures fatigue severity. The MFI-20 total score ranges from 0 to 80, with higher scores indicate more severe fatigue.
Time Frame
Baseline, week 4, week 8, and week 12.
Title
The change of the Pittsburgh Sleep Quality Index (PSQI) from baseline.
Description
Scores on the Pittsburgh Sleep Quality Index (PSQI) range from 0 to 21, with higher scores indicating worse sleep quality.
Time Frame
Baseline, week 4, week 8, and week 12.
Title
The Beck II Depression Inventory (BDI)
Description
The Beck II Depression Inventory (BDI) assesses the severity of depressive symptoms. Scores range from 0 to 39, with higher scores indicate a greater degree of depression severity.
Time Frame
Baseline, week 4, week 8, and week 12.
Title
The change of the Perceived Stress Scale (PSS) from baseline.
Description
The Perceived Stress Scale (PSS) is for measuring the perception of stress and current levels of experienced stress. Scores range from 0 to 56, with higher total score indicating a greater degree of symptom severity.
Time Frame
Baseline, week 4, week 8, and week 12.
Title
Global Impression of Change (PGIC) questionnaire evaluated at week 12.
Description
A questionnaire determine any change in overall symptom status from the beginning of the study to its conclusion (score range, 1 [very much improved] to 7 [very much worse).
Time Frame
Week 12.
Title
The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline.
Description
The Short Form-36 Health Status Questionnaire (SF-36), which measured health-related quality of life (range, 0 to 100, with higher scores indicating better perceived health status).
Time Frame
Baseline, week 4, week 8, and week 12.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: meet the 1990 American College of Rheumatology (ACR) Research Classification Criteria for fibromyalgia; be between the ages of 18 to 70 years. Exclusion Criteria: had practiced Ba-Duan-Jin, Tai Chi, yoga or other forms of Qigong exercise within 12 months of their recruitment to the study; be less than 40mm of pain VAS score; had renal failure, and severe depression or anxiety; had any poorly-controlled comorbid medical conditions, such as dementia, cancer, thyroid disease, inflammatory arthritis; pregnancy or planned pregnancy within the study period; patients residing more than 70 miles from the research site.
Facility Information:
Facility Name
Jiao Juan
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34292537
Citation
Yang Y, Li YT, Sun YR, Wang J, Li Y, Zhang JH, Jiao J, Jiang Q. Therapeutic Effects of Ba-Duan-Jin versus Pregabalin for Fibromyalgia Treatment: Protocol for a Randomized Controlled Trial. Rheumatol Ther. 2021 Sep;8(3):1451-1462. doi: 10.1007/s40744-021-00341-9. Epub 2021 Jul 22.
Results Reference
derived

Learn more about this trial

Comparison of Ba-Duan-Jin and Pregabalin in Patients With Fibromyalgia

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